FDA's Efforts to Help Reduce Drug Shortages
The Food and Drug Administration (FDA) has recently announced an effort to help prevent hundreds of drug shortages that have been occurring for more than 10 years.
The FDA discussed a current approach the organization has been using to restore drug shortages in order to reduce the number of patients affected. Thursday Congress discussed the strategic plan aimed at helping with these efforts in order to prevent any shortages, via the FDA's website.
At this time, the FDA is actively working with the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to help address public concerns caused by lack of critical medications that are necessary for many patients but may be on low supply.
Dr. Janet Woodcock, the director of the FDA's center for Drug Evaluation and Research said that while following the president's 2011 Executive Order on reducing drug shortages, the number of new shortages in 2012 was 117, which is down from 251 in 2011.
The FDA has also issued that all manufacturers of various products notify the FDA of a permanent discontinuance or temporary interruption when supplies are running short.
This rule also extends to manufacturers of medically important biological products, according to UPI.
"The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages," Woodcock said in a statement. "The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders."
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